DEPUY SYNTHES POWER TOOLS OSCILL-SAW-ATTACHM W/QUICK-COUPL F/COMPA; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
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Catalog Number 511.801 |
Device Problem
Partial Blockage (1065)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the housing and bearing, eccentric was worn out.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to normal wear and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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It was reported from (b)(6) that the attachment device was blocked when mounted to a device and switched on.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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